{"id":4487,"date":"2025-09-27T08:39:17","date_gmt":"2025-09-27T01:39:17","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=4487"},"modified":"2025-10-02T15:16:57","modified_gmt":"2025-10-02T08:16:57","slug":"calcitriol","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/calcitriol\/","title":{"rendered":"Calcitriol"},"content":{"rendered":"

(Ph. Eur. monograph 0883)<\/p>\n

Download PDF here.<\/p>\n

C27<\/sub>H44<\/sub>O3<\/sub>\u00a0 \u00a0 \u00a0 416.6\u00a0 \u00a0 \u00a0 32222-06-3<\/p>\n

Action and use<\/strong><\/p>\n

Vitamin D analogue.<\/p>\n

Preparation<\/strong><\/p>\n

Calcitriol Capsules<\/p>\n

DEFINITION<\/h2>\n

(1S,3R,5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-1,3,25-triol.<\/p>\n

Content<\/h3>\n

97.0 per cent to 102.0 per cent.<\/p>\n

A reversible isomerisation to pre-calcitriol takes place in solution, depending on temperature and time. The activity is due to both compounds (see Assay).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\n

White or almost white crystals.<\/p>\n

Solubility<\/h3>\n

Practically insoluble in water, freely soluble in ethanol (96 per cent), soluble in fatty oils.<\/p>\n

It is sensitive to air, heat and light.<\/p>\n

IDENTIFICATION<\/h2>\n

A. Infrared absorption spectrophotometry (2.2.24).<\/p>\n

Comparison: Ph. Eur. reference spectrum of calcitriol.<\/p>\n

B. Examine the chromatograms obtained in the assay.<\/p>\n

Results: The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (a).<\/p>\n

TESTS<\/h2>\n

Related substances<\/h3>\n

Liquid chromatography (2.2.29): use the normalisation procedure. Carry out the test as rapidly as possible, avoiding exposure to actinic light and air.<\/p>\n

Test solution: Dissolve 1.00 mg of the substance to be examined without heating in 10.0 mL of the mobile phase.<\/p>\n

Reference solution (a): Dissolve 1.00 mg of calcitriol CRS without heating in 10.0 mL of the mobile phase.<\/p>\n

Reference solution (b): Dilute 1.0 mL of reference solution (a) to 100.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 10.0 mL with the mobile phase.<\/p>\n

Reference solution (c): Heat 2 mL of reference solution (a) at 80 \u00b0C for 30 min.<\/p>\n

Column:<\/p>\n

\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n

\u2014 stationary phase: end-capped extra-dense bonded octylsilyl silica gel for chromatography R (5 \u03bcm);<\/p>\n

\u2014 temperature: 40 \u00b0C.<\/p>\n

Mobile phase: Mix 450 volumes of a 1.0 g\/L solution of tris(hydroxymethyl)aminomethane R adjusted to pH 7.0-7.5 with phosphoric acid R, and 550 volumes of acetonitrile for chromatography R.<\/p>\n

Flow rate: 1.0 mL\/min.<\/p>\n

Detection: Spectrophotometer at 230 nm.<\/p>\n

Injection: 50 \u03bcL.<\/p>\n

Run time: Twice the retention time of calcitriol.<\/p>\n

Relative retention: With reference to calcitriol (retention time = about 14 min): impurity C = about 0.4; pre-calcitriol = about 0.88; impurity A = about 0.95; impurity B = about 1.1.<\/p>\n

System suitability:<\/p>\n

\u2014 resolution: minimum 3.5 between the peaks due to pre-calcitriol and calcitriol in the chromatogram obtained with reference solution (c);<\/p>\n

\u2014 number of theoretical plates: minimum 10 000, calculated for the peak due to calcitriol in the chromatogram obtained with reference solution (a).<\/p>\n

Limits:<\/p>\n

\u2014 impurities A, B, C: for each impurity, maximum 0.5 per cent;<\/p>\n

\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n

\u2014 total: maximum 1.0 per cent;<\/p>\n

\u2014 reporting threshold: 0.05 per cent; disregard the peak due to pre-calcitriol.<\/p>\n

ASSAY<\/h2>\n

Liquid chromatography (2.2.29) as described in the test for related substances with the following modification.<\/p>\n

Injection: Test solution and reference solution (a).<\/p>\n

For both the test solution and reference solution (a), take into account, the sum of the areas of the peaks due to calcitriol and, when present, to pre-calcitriol.<\/p>\n

Calculate the percentage content of C27<\/sub>H44<\/sub>O3<\/sub> taking into account the assigned content of calcitriol CRS.<\/p>\n

STORAGE<\/h2>\n

Under an inert gas, in an airtight container, protected from light, at a temperature of 2 \u00b0C to 8 \u00b0C.<\/p>\n

The contents of an opened container are to be used immediately.<\/p>\n

IMPURITIES<\/h2>\n

Specified impurities A, B, C.<\/p>\n

\"Calcitriol\"<\/p>\n

A. (1S,3R,5E,7E)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol (trans-calcitriol),<\/p>\n

\"Calcitriol\"<\/p>\n

B. (1R,3R,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol (1\u03b2-calcitriol),<\/p>\n

\"Calcitriol\"<\/p>\n

C. 6\u03be-[(3S,5R)-3,5-dihydroxy-2-methylcyclohex-1-en-1-yl]-17\u03b2-[(2R)-6-hydroxy-6-methylheptan-2-yl]-2-phenyl-2,5,10- triaza-4-nor-9\u03be-estr-7-ene-1,3-dione.<\/p>\n","protected":false},"excerpt":{"rendered":"

(Ph. Eur. monograph 0883) Download PDF here. C27H44O3\u00a0 \u00a0 \u00a0 416.6\u00a0 \u00a0 \u00a0 32222-06-3 Action and use Vitamin D analogue. Preparation Calcitriol Capsules DEFINITION (1S,3R,5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-1,3,25-triol. Content 97.0 per cent to 102.0 per cent. A reversible isomerisation to pre-calcitriol takes place in solution, depending on temperature and time. The activity is due to both compounds (see…<\/p>\n","protected":false},"author":2,"featured_media":4495,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-4487","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4487","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=4487"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4487\/revisions"}],"predecessor-version":[{"id":5284,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/4487\/revisions\/5284"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/4495"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=4487"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=4487"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=4487"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}